Qualification and validation of utensil washers

Ensuring compliances in critical cleaning

The V-model is widely accepted as a methodology to verify and validate hygiene solutions in a critical cleaning process. The process of qualification and validation needs to ensure a safe and efficient cleaning process throughout the lifecycle of the system. Compliance with regulations and requirements in constant change is a key challenge in the pharmaceutical industry. Managed the right way, it allows for continual improvements.

A well written URS is paramount to execute a successful DQ, IQ, OQ and PQ. At the same time it is essential to ensure safety, efficacy and a uniform quality of APIs as well as compliance with cGMP regulations. Defining adequate requirements is often a complex process. Inadequate time and resources allocated to the definition of exact requirements often result in a poorly written URS which highly increase the risk of inadequate documentation, inconsistencies, budget overruns and project delays.

Though pre-determination of requirements is a time-consuming process, time is well spent when appropriate stakeholders are involved in the early stages of the process thus defining clear, concise and testable requirements.

A life cycle approach

The defined requirements are not only for the use of procurement as the cost of change is very high once the cleaning validation of the equipment has been carried out. Clear user requirements and testable acceptance criteria must be specified and evaluated to ensure a utensil washer is fit for purpose throughout the lifecycle of the system.

Despite the fact that reproducibility is highly essential to a safe and uniform production of APIs, evaluation of validated processes is equally necessary to ensure a higher quality and compliance with relevant GMP requirements through the entire lifecycle.

According to the FDA, cGMP requirements allow manufacturers of APIs to use modern technologies and innovative approaches to achieve higher quality through continual improvements.

cGMP requirements allow companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement.

Source: FDA

Besides compliance with relevant GMP requirements, a utensil washer must also comply with internal SOPs at the same time which places great demands on the company’s interactions.

Reviewing specifications together with the vendor during DQ enables a constructive dialogue. The dialogue is based on the company’s quality requirements and SOPs, EMA and FDA regulations and requirements as well as the company’s desire for continuous improvements.

Good engineering practice is – when all comes to all – to assist manufacturers in navigating between legal requirements, own SOPs and the objective to optimise their critical processes such as cleaning whilst ensuring an auditable and safe solution.

FACT

The European Medicines Agency received 161 suspected quality defect notifications in 2017. Of these, 140 cases were confirmed quality defects and led to batch recalls of 17 centrally authorised pharmaceuticals. 2 recalls were due to life-threatening or serious health risks.